Ashley America v. HHS - HPV, neurocardiogenic syncope (NCS) (2022)

On April 17, 2017, Maria and Rui America, on behalf of their then-minor child Ashley America, filed a petition alleging that the human papillomavirus (HPV) and influenza (flu) vaccines caused Ashley to develop neurocardiogenic syncope (NCS). Ashley America later became the named petitioner after turning 18 and restricted her claim to an off-Table significant aggravation of her preexisting NCS.

The petitioner's counsel was Renee J. Gentry of the Vaccine Injury Clinic, George Washington Univ.

Law School. The respondent's counsel was Amanda Pasciuto of the U.S.

Department of Justice. Chief Special Master Brian H.

Corcoran issued the decision denying entitlement. Ashley America, born January 28, 1996, had a medical history significant for episodic syncope dating back to 2009, characterized by loss of consciousness, occasional convulsive arm movements, and quick recovery.

Her last syncopal episode before vaccination occurred twenty-four days prior to her first HPV dose. On October 20, 2014, she received her first HPV vaccine dose along with the flu vaccine.

The day after vaccination, she experienced dizziness and fainted, leading to a diagnosis of vertigo. Over the next ten days, she had six more episodes.

Medical evaluations were inconsistent, with some suggesting syncope and others suggesting conversion disorder or pseudoseizures. Expert testimony conflicted.

Petitioner's expert, Dr. Svetlana Blitshteyn, a neurologist specializing in autonomic disorders, opined that the HPV vaccine caused or aggravated Ashley's NCS through molecular mimicry.

Respondent's expert, Dr. Jeffrey R.

Boris, a pediatric cardiologist, argued that Ashley suffered from psychogenic pseudosyncope (PPS) and that the HPV vaccine did not cause her condition. Dr.

Blitshteyn relied on Ashley's history of syncope and the temporal relationship between vaccination and the increase in her symptoms. She proposed that the HPV vaccine could trigger an autoimmune response via molecular mimicry, leading to dysautonomia.

She cited various studies suggesting a link between HPV vaccination and autonomic disorders like POTS and NCS. Dr.

Boris disputed the NCS diagnosis, arguing that Ashley's symptoms were more consistent with PPS or conversion disorder. He contended that the temporal relationship was too short for an autoimmune mechanism, that the medical literature cited by Dr.

Blitshteyn was unreliable or did not support causation, and that the HPV vaccine was not a likely cause of her condition. He noted that Ashley's blood pressure and heart rate did not consistently fall during episodes, and that she exhibited signs of consciousness during some events, inconsistent with true syncope.

He also highlighted that a tilt table test, often used to diagnose syncope, was not performed. Chief Special Master Corcoran denied entitlement, finding that Ashley America did not preponderantly establish that the HPV vaccine could aggravate NCS or that it did so in her case.

The Special Master found the temporal relationship of one to two days post-vaccination too short for the proposed autoimmune mechanism. The court found Dr.

Blitshteyn's causation theory unreliable and unsupported by preponderant evidence. The court also noted the lack of definitive diagnosis and incomplete testing, such as the absence of a tilt table test.

The Special Master concluded that the HPV vaccine did not likely worsen her syncopal episodes and that the medical record did not support the petitioner's contention that the vaccine could or did exacerbate her NCS. The decision was made on the record without a hearing.